EP4520340A2 - Systeme zur abgabe von zell- und biologischen materialien mittels ultraschall zur wundbehandlung und wundheilung - Google Patents

Systeme zur abgabe von zell- und biologischen materialien mittels ultraschall zur wundbehandlung und wundheilung Download PDF

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Publication number
EP4520340A2
EP4520340A2 EP25152883.2A EP25152883A EP4520340A2 EP 4520340 A2 EP4520340 A2 EP 4520340A2 EP 25152883 A EP25152883 A EP 25152883A EP 4520340 A2 EP4520340 A2 EP 4520340A2
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European Patent Office
Prior art keywords
fluid
treatment
cellular
wand
delivery
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EP25152883.2A
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English (en)
French (fr)
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EP4520340A3 (de
Inventor
Douglas J Duchon
Mohit Bhatia
Janice M SMIELL
Ryan Glen Tetzloff
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Sanuwave Health Inc
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Sanuwave Health Inc
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Publication of EP4520340A2 publication Critical patent/EP4520340A2/de
Publication of EP4520340A3 publication Critical patent/EP4520340A3/de
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61N7/00—Ultrasound therapy
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
    • A61K35/19—Platelets; Megacaryocytes
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/48—Reproductive organs
    • A61K35/50—Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/005—Sprayers or atomisers specially adapted for therapeutic purposes using ultrasonics
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    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0092—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0803—Counting the number of times an instrument is used
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    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
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    • A61B90/94—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text
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    • A61B90/98—Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0059—Heating or cooling appliances for medical or therapeutic treatment of the human body with an open fluid circuit
    • A—HUMAN NECESSITIES
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    • A61M2037/0007—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
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    • A61M2205/00—General characteristics of the apparatus
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    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/3626—General characteristics of the apparatus related to heating or cooling by controlled mixing of fluids at different temperatures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
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    • A61N2007/0078—Ultrasound therapy with multiple treatment transducers

Definitions

  • Embodiments relate generally to systems and methods for delivering cellular and/or biological materials using ultrasound for wound treatment and healing, and more particularly to a non-contact, low-frequency, highly efficient ultrasound therapy and biologic delivery system that delivers ultrasonic therapy treatments while distributing and biologic or cellular materials via a mist to a patient skin or tissue to promote healing and provide a cover to denuded, damaged and/or inadequate tissues.
  • Biologic products including extracellular matrices, naturally occurring proteins, growth factors and adherent cell populations, are important components in the healing process. Additionally, further administration of biologic materials, either taken from autologous or allogenic sources, are capable of covering, supporting and/or enhancing the healing progress of partial- or full-thickness wounds. Moreover, some biologic materials are capable of being administered topically. Administration of some biologic components may result in modulation of inflammation that is additive or synergistic with that of ultrasound energy.
  • Embodiments relate to biologic and/or cellular material delivery and non-contact, low-frequency, highly efficient ultrasound therapy devices, systems and methods that deliver ultrasonic and biologic therapy treatments via a mist to a patient wound to promote wound healing.
  • One embodiment is directed to a non-contact, medical ultrasound therapy system for generating and controlling low frequency ultrasound alongside delivery of biologic for promoting wound healing.
  • the ultrasound therapy system includes a treatment wand including an ultrasonic transducer, a generator unit, a cable coupling the treatment wand to the generator unit, and a biologic and cellular material delivery mechanism.
  • the generator unit generates electric power output to drive the ultrasonic transducer and includes a digital frequency generator, wherein the generator unit digitally controls energy output at resonance frequency of the ultrasonic transducer.
  • the invention also provides methods for treating a skin, mucosa, or other condition.
  • these methods involve using an ultrasound delivery device to apply to an area of skin, mucosa or other tissue affected by the condition a mist that comprises a micronized cellular or biological material.
  • the skin or other condition can be, for example, a wound, ulcer, or other condition.
  • the cellular or biological material is, in some embodiments, a placental extracellular matrix composition or a placental connective tissue matrix composition. These compositions can be prepared from, for example, whole placental, placental deciduas, placental amniotic membrane, or placental chorionic membrane.
  • the biological material includes a population of adherent cells, or a mixture of adherent and non-adherent cells.
  • the cellular or biological material can also include platelet-rich plasma or placental perfusate.
  • the cellular or biological material is micronized in some embodiments of the invention.
  • medical ultrasound devices for delivering non-contact ultrasound therapies to a skin or other condition.
  • These devices can include at least one treatment wand that includes an ultrasonic transducer, at least one reservoir that contains a fluid or suspension that includes a micronized cellular or biological material; and a pump that is in fluid communication with the reservoir and the treatment wand to deliver the fluid to the treatment wand such that the ultrasonic transducer atomizes the cellular or biological material as the cellular or biological material passes through the treatment wand for delivery to the area of skin or other tissue that is affected by the condition.
  • the devices of the invention have a plurality of treatment wants and/or a plurality of reservoirs.
  • Each treatment wand can be in fluid communication with one reservoir, or a treatment wand can be in fluid communication with more than one reservoir.
  • at least one of the reservoirs contains a fluid for cleaning or disinfecting a wound or other tissue.
  • a fluid for debriding a wound or tissue, or a fluid for providing a protective or other coating on a wound or other tissue can also be contained within one or more of the reservoirs.
  • the reservoir(s) are sterile, in some embodiments, and the fluid that is contained in the reservoir(s) can also be sterile.
  • the medical ultrasound devices of the invention further include an applicator configured to be coupled to the treatment wand, wherein the applicator has a radio frequency identification (RFID) tag and the treatment wand has a RFID transceiver that is used to identify the RFID tag on the applicator to ensure that the applicator is limited to a single use.
  • RFID radio frequency identification
  • the devices of the invention also include, in some embodiments, a microprocessor that is configured to control operation of the device.
  • the treatment wand can include, in some embodiments, a plurality of tubes and a plurality of reservoirs, each tube in fluid communication with a different one of the plurality of reservoirs, and a microprocessor that is configured to control a delivery pattern of fluids from the plurality of reservoirs.
  • the delivery pattern can be, in some embodiments, sequential delivery of individual fluids or simultaneous delivery of at least two fluids.
  • the devices can also include at least one valve that is configured to selectively couple at least one of the reservoirs to a treatment wand.
  • the valve can include, for example, a static mixer.
  • the microprocessor can be configured to control operation of the valve(s) and the device.
  • the valve can also be manually controllable.
  • Skin and/or mucosal ulcers or wounds which are breaks in the skin/mucosa located anywhere on the surface of the body or its cavities, are a common occurrence.
  • Healing of these wounds may be complicated by concomitant disease states, making them difficult or slow to heal (i.e., chronic).
  • Wounds may be acute but difficult to treat because of location or association with concomitant conditions or injuries and require more innovative treatment than simple or routine good wound care to accomplish a functional regenerative repair or significant pain relief.
  • Acute wounds are usually the result of accidental (e.g., burn or trauma) or iatrogenic (e.g., surgery) injuries.
  • Chronic wounds afflict certain patient populations, particularly the elderly, immobile, obese, under-exercised, or with comorbidities like diabetes, atherosclerosis or autoimmune/inflammatory conditions, while acute wounds are ubiquitous.
  • Chronic wounds may initiate as acute wounds that are complicated by the presence of a disease state or become infected, causing them to require more than four to six weeks to heal.
  • Chronic wounds are persistent, non-healing or slow-healing wounds in which the body's healing process becomes stalled. They require treatment of the underlying disease state in parallel to treatment of the wound to achieve healing.
  • a regenerative healing process is desired.
  • application of human tissue components that maintain their architecture and/or biochemical construct have been shown to increase the likelihood of a regenerative repair that minimizes fibrosis and maximizes the functional and aesthetic outcomes.
  • Skin ulcers have been treated by application of a variety of skin substitutes or dressings, such as xenografts, which can include extracellular matrix products derived from porcine/bovine/equine/ovine/piscine sources.
  • Conventional products include living bi-layered skin substitutes comprised of dermal layer and epidermal layers with a synthetic and/or animal-derived matrix, human acellular dermal matrix products that are derived from donated human skin, or donated human skin that is cryopreserved to maintain living cells in the bilayer construct.
  • Dressings that are considered skin substitutes include the products that include plant-sourced advanced matrices.
  • the skin substitutes have disadvantages that include difficulty in handling, storing, sourcing or manufacturing challenges and size limitations.
  • a need for a method of supporting or promoting the healing of wounds using a flexible, readily-available, customizable, easily applied durable material that can facilitate healing of the ulcerated or wounded area Other needs also exist, including for treating conditions other than wounds (e.g., psoriasis, eczema, and other rashes and skin conditions that significant inflammation associated therewith).
  • wounds may be used as examples herein throughout, treatment areas need not comprise wounds per se and can comprise areas of the skin or body afflicted by some condition or otherwise viewed by a medical professional as potentially responsive to therapy or treatment.
  • a low-frequency ultrasound therapy device and system configured for use with biologic and cellular material delivery and therapy.
  • Many of the substantial technical obstacles to providing such a device based on the requirements of conventional ultrasound therapy devices are recognized and overcome by this disclosure. Specifically, making devices more readily accessible to additional patient populations by treating a more diverse set of ailments or conditions with new materials and techniques has been a significant challenge now met, at least in part, by embodiments discussed in this disclosure.
  • biologic or cellular and biologic materials using ultrasound therapy systems described herein, however, address many or all of the technological, patient tolerance, and clinical effectiveness obstacles of the past and provide a lower-power, safer, more efficient, and more accessible ultrasound system for delivery of and therapy by biologic or cellular materials. Even battery powered systems are possible in certain embodiments.
  • treatment, acceleration, and support or promotion of healing may be achieved by providing an optimal selection of ultrasound parameters such as frequency, intensity, pulse length, beam characteristics, and application time on the skin to enhance the transportation of biological cellular agents into the epidermal, dermal and subcutaneous tissues.
  • topical agents of cellular materials that cannot normally penetrate the skin or mucosa with current methods may be transported into the dermis or submucosa. Accordingly, designs for new biologic and cellular material delivery and medical ultrasound devices, systems and methods incorporating various features, concepts and improvements, are discussed in the following pages.
  • Cellular and/or biological materials suitable for use in embodiments can be prepared and delivered in many formats. Biologic materials or viable tissue can be harvested and processed via several methodologies in order to create a fine particulate. In some embodiments, micronized or particulate cellular or biological materials are created through an aseptic mechanical milling process that creates a desired or appropriate size of particle. Examples of suitable milling processes include ball milling, jet milling, impact milling and friction milling. Other milling or processing methodologies to micronize the cellular or biological material can be used in other embodiments, such as grinding.
  • the particles of cellular or biological material can be sized to be smaller than a delivery orifice of a delivery mechanism of the ultrasound device, or the delivery orifice can be selected for use according to a known particulate size in a specific application.
  • the particle size is less than about 60 micrometers ( ⁇ m), for example less than about 30 ⁇ m in some embodiments, or between about 20 ⁇ m and 30 ⁇ m in one embodiment.
  • the particle size also can be considered relative to atomized droplet size, when a fluid in which undissolved particles are suspended is atomized. In one embodiment, the particle size is less than or about 1/10 of the size of the atomized droplet.
  • Particle size also can affect or depend upon the viscosity of the fluid in which the particles are suspended or dissolved, and fluids with viscosities of less than or about 100 centipoise can be advantageous in some embodiments, though fluids with higher viscosities still may be used in other embodiments. Because atomized droplet size depends on fluid viscosity and frequency, adjustments can be made to one or more characteristics, for different applications or situations.
  • various tissues and cells can be combined to create a mixture of biologics that are optimized for a particular application, therapy, patient or other characteristic. Additionally, characteristics of the fluid for atomization and/or the device that atomizes the fluid can be adjusted or optimized for a particular application, therapy, patient or other characteristic.
  • the cellular or biological material can comprise a population of an adherent cells, such as fibroblasts or mesenchymal stem cells (MSCs).
  • the cells can be a mix of different cell types or a homogenous population.
  • cells can be derived from the patient or placental sources. Patient-sourced cells can be taken from a biopsy of skin or other tissue, and the tissue can be homogenized. The cells can be separated using a variety of commercial methods including plating cells on a tissue culture plate to enrich an adherent cell population.
  • the cellular or biological material can comprise a mixture of adherent and non-adherent cells.
  • perfusate sources contain a mix of adherent and non-adherent cell types.
  • the perfusate can be plated on tissue culture plates, populated and later removed using a variety of well-known methods, including the use of a collagenase solution.
  • the cells can be diluted into an appropriate pH balanced buffer, such as phosphate-buffered saline.
  • An additive can be added to the cell buffer to improve cell viability and passage through the ultrasound device.
  • the placenta tissue itself can serve as a source of cells. Cells can be derived from an umbilical cord, the Wharton's jelly or the placental decidua.
  • the tissue can be scraped and partly homogenized using mechanical or chemical methodologies, followed by plating the cells upon a tissue culture plate.
  • the cells can be removed from the plate and mixed with a benign buffer.
  • Cells can be autologous or allogeneic with immunomodulatory properties.
  • only a single fluid is delivered at any time, via one of tubes 120a-c.
  • a plurality of fluids can be delivered sequentially or in some other order. This can be controlled by a microprocessor controlling, e.g., a series of pumps each coupled with tubes 120a-c and discussed in more detail below.
  • two or more fluids or materials can be delivered simultaneously to applicator 80 for mixing at orifice 82.
  • FIG. 9d shows tuning mode 720.
  • the tuning mode voltage is set at 722.
  • the current loop is set off at 724, followed by a search for the resonance frequency Fr of ultrasonic transducer 70 at 726. If the resonance frequency is found at 728, the system continues on to 738. If the resonance frequency is not found, the system will try again for a set number of times at 730. If resonance frequency is not found, after these attempts, an error is displayed on the system display 206 at 734, followed by system shutdown at 736.
  • the current is set for the ultrasonic transducer 70.
  • the operation frequency is set at 756 and the voltage and current phase is measured at 758. See FIG. 9b .
  • monitoring the system commences at 760.
  • FIG. 9f shows monitoring the system at 760.
  • the system monitors: the temperature of the generator unit 30; the temperature of the treatment wand 40; the temperature of the case of the ultrasonic transducer 70; the output voltage of the ultrasonic transducer 70; the current of the pump 50; and the communication between the two microprocessors 200 and 316 (MCU2 and MCU1).
  • additional sensing e.g., tissue temperature
  • error codes are generated and communicated at 764 before returning to 766.
  • the system then tests to see if the treatment has timed out at 776. If it has not timed out, operation reverts to 740 and the test of 90 minute RFID time limit is conducted. If treatment has timed out at 776, the treatment is stopped at 778 followed by the option to add a further treatment at 780. If another treatment is desired, another treatment is added at 782 and operation reverts to the tuning mode at 720. If no further treatment is desired, information is saved at 784.
  • FIG. 9g shows saving information 784 in greater detail.
  • the system collects device setup information, device operation information, and user treatment information at 786.
  • information is saved to EEPROM before continuing to system shutdown at 770.
  • both microprocessor 200 and microprocessor 316 are configured to individually suspend operation of the ultrasonic system in fault condition situations. This arrangement provides enhanced safety not present in other types of designs.
  • FIGS. 10a-10d are flowcharts that illustrate examples related thereto. In all cases, what is depicted in the figures and discussed herein is but an example embodiment, and other embodiments may include additional tasks not specifically depicted or discussed, omit tasks that are depicted or discussed, or reorder tasks. Additionally, tasks or features from different figures may be combined in other embodiments.
  • FIG. 10b Another example depicted in FIG. 10b relates to embodiments in which a plurality of biologic/cellular materials is prepared and applied to a wound other area for treatment.
  • a first biologic/cellular material is prepared.
  • a second biologic/cellular material is prepared.
  • multiple biologics are combined or mixed at 1012. This can be accomplished, for example, by valving or other features of system 10, or the materials or solutions can be mixed and combined in a container or combined in some other way.
  • the mixture is applied to the wound or other treatment area by system 10.
  • the first and second materials can be applied via system 10 sequentially, as shown at 1016 and 1018.
  • a liquid solution such as saline or phosphate buffered saline
  • a third or other additional materials can be applied, or different combinations of the tasks at 1012, 1014, 1016 and/or 1018 can be carried out in other embodiments. Delivery of the various materials and/or solutions can be accomplished and controlled by pumps, valving, multiple treatment wands and/or other features of various embodiments of system 10, as discussed above.
  • a biologic/cellular material can be prepared as a topical application 1022.
  • the topical application can be a cellular sheet, powderized/lyophilized material, jet milled, a cream, liquid solution, or any combination thereof, as previously discussed.
  • sterile saline solution, other liquid solutions, or other treatments or therapies can be applied to the wound or treatment area via system 10 at 1026.
  • additional tasks can be included.
  • a cleaning or disinfectant substance can be applied to the treatment area prior to application of the biologic/cellular material.
  • a biologic/cellular material can then be prepared at 1030 and applied to the wound or treatment area at 1032.
  • a liquid solution or second biologic/cellular material optionally can be applied at 1034 to the wound or treatment area.
  • a protective coating or biologic enhancing or activating material can be applied to the wound or treatment area at 1036.
  • embodiments can reduce the aesthetic insult of scarring and provide more functional (regenerative) benefits than fibrotic results from an impaired healing process. Also, embodiments may be used to activate a bioglue or other molecule or material that can form an effective "new skin” barrier to a wound or tissue.
  • a method of treating a skin, mucosa, or other condition comprises using an ultrasound delivery device to apply to an area of skin, mucosa or other tissue affected by the condition a mist that comprises a micronized cellular or biological material.
  • the cellular or biological material can comprise a placental extracellular matrix composition or a placental connective tissue matrix composition.
  • the placental extracellular matrix composition or placental connective tissue matrix composition can be prepared from whole placenta, placental deciduas, placental amniotic membrane, or placental chorionic membrane.
  • the cellular or biological material can comprise a population of adherent cells.
  • the cellular or biological material can comprise a mixture of adherent and non-adherent cells.
  • the cellular or biological material can comprise platelet rich plasma or placental perfusate.
  • the cellular or biological material can be micronized by grinding, milling, freeze drying, or heat drying.
  • the skin condition can comprise a wound.
  • a medical ultrasound device for delivering non-contact ultrasound therapies to a skin or other condition comprises at least one treatment wand comprising an ultrasonic transducer; at least one reservoir that contains a fluid or suspension comprising a micronized cellular or biological material; and a pump that is in fluid communication with the reservoir and the treatment wand to deliver the fluid to the treatment wand such that the ultrasonic transducer atomizes the cellular or biological material as the cellular or biological material passes through the treatment wand for delivery to the wound or other tissue.
  • the the device can comprise a plurality of treatment wands and a plurality of reservoirs, wherein each treatment wand is in fluid communication with one of the reservoirs.
  • the at least one of the plurality of reservoirs can contain a fluid for cleaning or disinfecting the area of skin or other tissue that is affected by the condition.
  • the fluid can be for debriding a wound or tissue.
  • the at least one of the reservoirs can contain a fluid for providing a protective or other coating on a wound or other tissue.
  • the at least one reservoir can be sterile.
  • the device can further comprise an applicator configured to be coupled to the treatment wand, wherein the applicator comprises a radio frequency identification (RFID) tag and the treatment wand comprises a RFID transceiver that is used to identify the RFID tag on the applicator to ensure that the applicator is limited to a single use.
  • the device can further comprise a microprocessor configured to control operation of the device.
  • the at least one treatment wand can comprise a plurality of tubes and the device comprises a plurality of reservoirs, each tube in fluid communication with a different one of the plurality of reservoirs, and wherein the microprocessor is configured to control a delivery pattern of fluids from the plurality of reservoirs.
  • the delivery pattern can be sequential delivery of individual fluids or simultaneous delivery of at least two fluids.
  • the medical ultrasound device can comprise one treatment wand and a plurality of reservoirs, wherein the device further comprises at least one valve configured to selectively couple at least one of the plurality of reservoirs to the treatment wand.
  • the at least one valve can comprise a static mixer.
  • the device can comprise a microprocessor configured to control operation of the device and the at least one valve.
  • the at least one valve can be manually controllable.
  • the medical ultrasound device can further comprise a nozzle coupled to the treatment wand and configured to provide fluid from the at least one reservoir to the at least one treatment wand.
  • the medical ultrasound device can further comprise a temperature control unit configured to heat or cool the fluid from the at least reservoir before the fluid is delivered to the treatment wand.
  • the medical ultrasound device can further comprise a temperature control device configured to be coupled with the at least one reservoir to heat or cool the fluid contained therewithin.
  • the treatment wand can comprise a motion processing unit and a user interface, wherein the user interface is configured to receive data from the motion processing unit and provide feedback to a user regarding positioning of the treatment wand during use of the device.
  • the motion processing unit can be configured to adjust a characteristic of the device based on the received data related to positioning of the treatment wand during use of the device.
  • the characteristic can be at least one of a flow rate of the fluid or a frequency of the ultrasonic transducer.
  • the feedback can be at least one of visual feedback, audible feedback or haptic feedback.
  • the at least one reservoir can comprise a machine-readable component, and the device can comprise a reader configured to read the machine-readable component and do at least one of: confirm that the fluid is for use with a particular patient; confirm a content of the reservoir; prompt a user to read, using the reader, a corresponding machine-readable patient identifier before use of the device; or receive device programming information from the machine-readable label.
  • the machine-readable component can be a wirelessly machine-readable component, a radio frequency identification (RFID) tag, a bar code, or a Quick Response (QR) code.
  • the medical ultrasound device can further comprise a reader configured to read a machine-readable component on a component or accessory of the device to confirm that the component or accessory is usable with the device.
  • the medical ultrasound device can further comprise at least one mixer to mix the fluid in the at least one reservoir.
  • the at least one mixer can mix the micronized cellular or biological material and the fluid.
  • the at least one mixer can mix the fluid in a first one of the at least one reservoir with the fluid in at least a second one of the at least one reservoir.
  • the at least one mixer can be a static mixer or a vibration mixer.
  • At least one characteristic of the device can be variable to produce a variable spray pattern for delivery to the wound or other tissue.
  • At least one characteristic of the device can be a size of an orifice of an applicator of the treatment wand, a shape of the orifice of the applicator of the treatment wand, a characteristic of the applicator of the treatment wand, a characteristic of a tip of an ultrasonic transducer of the treatment wand, or a flow rate of the fluid.
  • the medical ultrasound device can further comprise a disposable kit comprising a single-use applicator coupleable to the treatment wand, tubing to convey the fluid from the reservoir to the treatment wand, and a spike to pierce the reservoir to couple the tubing to the reservoir.
  • the kit can further comprise at least one of a valve or a disposable mixer.
  • a method of promoting wound healing comprises providing a micronized cellular or biological material to be applied to the wound as a mist formed by an ultrasound delivery device.
  • the cellular or biological material can comprise a placental extracellular matrix composition or a placental connective tissue matrix composition.
  • the placental extracellular matrix composition or placental connective tissue matrix composition can be prepared from whole placenta, placental desidua, placental amniotic membrane, or placental chorionic membrane.
  • the cellular or biological material can comprise a population of adherent cells.
  • the cellular or biological material can comprise a mixture of adherent and non-adherent cells.
  • the cellular or biological material can comprise platelet rich plasma or placental perfusate.
  • the cellular or biological material can be micronized by grinding, milling, freeze drying, or heat drying.
  • a method of promoting wound healing comprises providing a micronized cellular or biological material to be applied to the wound manually followed by a mist formed by an ultrasound delivery device.
  • the cellular or biological material can comprise a placental extracellular matrix composition or a placental connective tissue matrix composition.
  • the placental extracellular matrix composition or placental connective tissue matrix composition can be prepared from whole placenta, placental amniotic membrane, or placental chorionic membrane.
  • the cellular or biological material can comprise a population of adherent cells.
  • the cellular or biological material can comprise a mixture of adherent and non-adherent cells.
  • the cellular or biological material can comprise platelet rich plasma or placental perfusate.
  • the cellular or biological material can be micronized by grinding, jet milling, freeze drying, or heat drying.
  • system 10 and/or its components or systems include computing devices, microprocessors, modules and other computer or computing devices, which can be any programmable device that accepts digital data as input, is configured to process the input according to instructions or algorithms, and provides results as outputs.
  • computing and other such devices discussed herein can be, comprise, contain or be coupled to a central processing unit (CPU) configured to carry out the instructions of a computer program.
  • CPU central processing unit
  • Computing and other such devices discussed herein are therefore configured to perform basic arithmetical, logical, and input/output operations.
  • Memory can comprise volatile or non-volatile memory as required by the coupled computing device or processor to not only provide space to execute the instructions or algorithms, but to provide the space to store the instructions themselves.
  • volatile memory can include random access memory (RAM), dynamic random access memory (DRAM), or static random access memory (SRAM), for example.
  • non-volatile memory can include read-only memory, flash memory, ferroelectric RAM, hard disk, floppy disk, magnetic tape, or optical disc storage, for example.
  • the system or components thereof can comprise or include various modules or engines, each of which is constructed, programmed, configured, or otherwise adapted, to autonomously carry out a function or set of functions.
  • engine as used herein is defined as a real-world device, component, or arrangement of components implemented using hardware, such as by an application specific integrated circuit (ASIC) or field-programmable gate array (FPGA), for example, or as a combination of hardware and software, such as by a microprocessor system and a set of program instructions that adapt the engine to implement the particular functionality, which (while being executed) transform the microprocessor system into a special-purpose device.
  • ASIC application specific integrated circuit
  • FPGA field-programmable gate array
  • An engine can also be implemented as a combination of the two, with certain functions facilitated by hardware alone, and other functions facilitated by a combination of hardware and software.
  • at least a portion, and in some cases, all, of an engine can be executed on the processor(s) of one or more computing platforms that are made up of hardware (e.g., one or more processors, data storage devices such as memory or drive storage, input/output facilities such as network interface devices, video devices, keyboard, mouse or touchscreen devices, etc.) that execute an operating system, system programs, and application programs, while also implementing the engine using multitasking, multithreading, distributed (e.g., cluster, peer-peer, cloud, etc.) processing where appropriate, or other such techniques.
  • hardware e.g., one or more processors, data storage devices such as memory or drive storage, input/output facilities such as network interface devices, video devices, keyboard, mouse or touchscreen devices, etc.
  • multitasking multithreading
  • distributed e.g., cluster, peer-peer, cloud, etc.
  • each engine can be realized in a variety of physically realizable configurations, and should generally not be limited to any particular implementation exemplified herein, unless such limitations are expressly called out.
  • an engine can itself be composed of more than one sub-engines, each of which can be regarded as an engine in its own right.
  • each of the various engines corresponds to a defined autonomous functionality; however, it should be understood that in other contemplated embodiments, each functionality can be distributed to more than one engine.
  • multiple defined functionalities may be implemented by a single engine that performs those multiple functions, possibly alongside other functions, or distributed differently among a set of engines than specifically illustrated in the examples herein.

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EP25152883.2A 2016-07-29 2017-07-28 Systeme zur abgabe von zell- und biologischen materialien mittels ultraschall zur wundbehandlung und wundheilung Pending EP4520340A3 (de)

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US201662368297P 2016-07-29 2016-07-29
PCT/US2017/044323 WO2018022968A1 (en) 2016-07-29 2017-07-28 Systems and methods for delivering cellular and biological materials using ultrasound for wound treatment and healing
EP17835325.6A EP3490673B8 (de) 2016-07-29 2017-07-28 Systeme zur bereitstellung von zell- und biologischen materialien mittels ultraschall zur wundbehandlung und wundheilung

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EP17835325.6A Division-Into EP3490673B8 (de) 2016-07-29 2017-07-28 Systeme zur bereitstellung von zell- und biologischen materialien mittels ultraschall zur wundbehandlung und wundheilung

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US20210275834A1 (en) 2021-09-09
EP3490673B1 (de) 2025-01-22
CA3032390A1 (en) 2018-02-01
EP4520340A3 (de) 2025-06-04
WO2018022968A1 (en) 2018-02-01
AU2017302612A1 (en) 2019-03-14
AU2022235565A1 (en) 2022-10-13
DK3490673T3 (da) 2025-04-07
EP3490673B8 (de) 2025-02-26
AU2024227630A1 (en) 2024-11-14
EP3490673A4 (de) 2020-07-22

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